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1° Fica aprovada a Farmacopeia Brasileira, 5ª edi&231 &227 o, constitu&237 da de Volume 1 M&233 todos Gerais e textos e Volume 2 Monografias. 2° Os insumos farmac&234 uticos, os medicamentos e outros produtos sujeitos &224 vigil&226 ncia sanit&225 ria devem atender &224 s normas e especifica&231 &245 es estabelecidas na Farmacopeia Brasileira.In Brazil, in order for a pharmaceutical company to register a drug form as generic or ‘similar’ with the Brazilian food and drug agency (Anvisa), it must be proved bioequivalent to its innovatory branded form (reference drug). This requires comparative trials, carried out in conformity with official compendia (Brazilian Pharmacopeia or another officially recognized code).

All tests were carried out by methods specified in the Brazilian Pharmacopeia 4th edition (Farmacopeia Brasileira IV). The following tests were performed: uniformity of mass, friability, disintegration time, hardness, assay, uniformity of dosage units, salicylic acid limit assay, dissolution and identification. The dissolution profile was also recorded, as recommended in RDC 31/2010. Whereas every sample was approved in all the Farmacopeia Brasileira IV tests, the results in the dissolution profile test showed that four of the test drugs (G1, G2, S1 and S2) were not pharmaceutically equivalent to drug R.

Por&233 m, h&225 necessidade de alinhamento entre os pr&243 prios documentos da Farmacopeia Brasileira (Farmacopeia e Formul&225 rio de Fitoter&225 picosFFFB1: Planta da Farmacopeia Brasileira PANC: Planta Alimentcia No Convencional. Inovado por meio da Farmacopeia Brasileira, oferecendo monografias para drogas vegetais que n&227 o est&227 o contempladas nos outros comp&234 ndios. Agncia Nacional de Vigilncia Sanitria.

The results of all analyses allow us to conclude that the dry extract of guava leaves has promising activity to be applied topically in the oral cavity or in the development of antitumor formulation or even be used as a functional food. IC50 of the extract tested in the HeLa, RKO and Wi cell lines was 15.6 ± 0.8 μg/ml, 21.2 ± 1.1 μg/ml and 68.9 ± 1.5 μg/ml, respectively. The MIC value was 250 μg/ml for Streptococcus mutans, Streptococcus mitis and Streptococcus oralis. The LD50 was 185.15 μg/ml.